A review of the trending news in oncology online for the week of January 8, 2021, including recent news from the FDA on the cancer treatment paradigm, updates in oncology, and the latest information regarding COVID-19.
This week in oncology news, the FDA granted a Breakthrough Therapy designation to the first anti-TIGIT therapy, tiragolumab, in combination with atezolizumab (Tecentriq) for the frontline treatment of patients with PD-L1-high metastatic non–small cell lung cancer. The FDA also lifted a partial clinical hold on a phase 2 study in AML, which is aimed to evaluate MT-401 as treatment of patients with post-transplant acute myeloid leukemia.
The FDA granted a Fast Track designation to ARX788 as a single agent for the treatment of patients with advanced or metastatic HER2-positive breast cancer who received at least 1 prior anti-HER2 regimen in the metastatic setting.
The FDA deferred action on the Biologics License Application for the potential biosimilar of bevacizumab (Avastin), MYL-1402O, due to travel restrictions related to coronavirus disease 2019 (COVID-19) that prohibited the agency from completing an inspection of the manufacturing facility, as required by the standard review process.
An Independent Data Monitoring Committee has recommended the pivotal phase 3 SIERRA study continue as planned to full enrollment of 150 patients based on the findings from a pre-planned ad hoc interim analysis of the study.
Bristol Myers Squibb has withdrawn the indication of nivolumab (Opdivo) for the treatment of patients with small cell lung cancer who had disease progression after a platinum-based chemotherapy and at least 1 other line of therapy from the United States market following a consultation with the FDA.
Treatment with the combination of eprenetapopt (APR-246) and azacitidine (Vidaza) did not improve complete responses in patients with TP53-mutant myelodysplastic syndromes when compared with azacitidine alone, missing the primary end point of a phase 3 clinical trial.
Maha Hussain, MD, of the Northwestern University Feinberg School of Medicine, discusses the current role of PARP inhibitors in the treatment landscape of prostate cancers and where she sees this therapeutic approach evolving in the coming years.
Masahiro Tsuboi, MD, of the National Cancer Center Hospital East in Japan, discusses the findings from the phase 3 ADAURA clinical trial of osimertinib (Tagrisso) as treatment of patients with EGFR-mutated non–small cell lung cancer.
Response from oncologists and other clinicians who participated in a series of online educational seminars and Twitter polls showed that the conversion of follow-up visits to telemedicine for patients with lung cancer continues to expand, mainly due to effects of the COVID-19 pandemic.
Since the start of the COVID-19 pandemic, visits to doctor’s offices and infusion centers dramatically declined in an attempt to reduce patient exposure to the virus, which led to delays in the delivery of certain therapies in the oncology setting.